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Dems’ Medicare win faces long, uncertain future

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Aug 09, 2022 View in browser
 
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By Katherine Ellen Foley , David Lim and Lauren Gardner

On Tap

— Medicare's looming ability to negotiate some drug prices is a massive feat for Dems, but the legislation's complexity leaves experts unsure of how it will exactly play out.

— The Biden administration will likely empower the FDA in the coming days with the ability to authorize emergency use of new monkeypox treatments, vaccines and tests.

— A study funded by the NIH is being cited to support a potential dose-sparing strategy for an FDA-approved monkeypox vaccine.

It's Tuesday. Welcome to Prescription Pulse. Do you have extra time for source coffees now that August recess is upon us? Reach out!

Send tips and feedback to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ).

 

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In Congress

Toby Anderson, 82, watches as his wife Amy, 83, divides his eight prescription drugs into a weekly schedule

For now, Medicare beneficiaries will be the only ones to directly benefit from CMS' negotiating powers. | Jeff Topping/Getty Images

SENATE DEMS ENABLE MEDICARE TO NEGOTIATE (SOME) DRUG PRICES — Senate Democrats pushed through a provision of the Inflation Reduction Act that would allow Medicare to negotiate prescription drug prices with drugmakers. The bill passed in a 51-50 vote Sunday morning. The section within the bill, which the House is expected to pass Friday, has been on the minds of lawmakers on both sides of the aisle in some form for more than a decade.

"This is a monumental step forward and tackling the costs of some of the most perniciously expensive prescription drugs in the Medicare program, drugs that have been on the market for substantial periods of time and yet don't face any generic competition," Sean Dickson, the director of health policy at the West Health Policy Center, a nonprofit organization focused on lowering health care costs, tells Katherine.

Negotiating will start with a narrow sliver of drugs: In 2026, Medicare will be able to negotiate the price of 10 predetermined prescription drugs patients can take at home. Those drugs, which fall under Medicare Part D, must have been on the market for at least nine years without any competition. The total annual amount the Centers for Medicare and Medicaid Services paid pharmacies most recently for the drugs will largely inform which products make the list. Then CMS and the drugmakers will negotiate the prices for the drugs that CMS will pay.

Medicare will add 15 more drugs to its negotiated list in next year and then again in the following year. In the third year, it will add 20 more drugs that, in some cases, may need a health care provider to administer. Drugs for which a generic comes to market will be removed from the list, and drug prices can be renegotiated if a drug reaches 13 years without a competitor.

Stunted growth? The pharmaceutical industry has argued that the negotiations will discourage competition and has threatened to fight the bill with litigation even after it is signed into law.

But experts say that may not be the case. There will always be demand for better therapies — whether they are more effective or easier to take. "You can still capture a larger market share of the unmet medical need by developing a therapy that is more patient-accessible," Dickson said.

Rachel Sachs, a law professor at Washington University in St. Louis who specializes in innovation policy and drug regulation, thinks the provision may encourage competition, at least for some types of drugs. "You could imagine that it would be in a biologic manufacturer's interest to allow biosimilar competition rather than to be eligible for negotiation," she told Prescription Pulse.

"What this [bill] does is say, 'Let's look at how price declines usually happen when generics come on the market and let's try and mimic that set of price changes,'" said Dickson.

Beyond negotiation: For now, Medicare beneficiaries would be the only ones to directly benefit from CMS' negotiating powers and an annual $2,000 out-of-pocket limit on drug spending in the provision. People on Medicare who use insulin would also benefit from that drug's $35 out-of-pocket copay cap.

The bill also requires drug companies to pay a rebate to Medicare if they raise prices faster than inflation. Even though the Senate parliamentarian stripped private insurance from the provision, Dickson argues that it will still ultimately affect the commercial market: "Inflation penalty on only a part of the market does hold down price growth for the entire market, but it won't do it in the one-to-one perfect way that the legislation has been intending," he said.

Experts still don't have a clear picture of the total impact of these provisions. "There have been other efforts and will continue to be other efforts — legislative, administrative and economic — to try to make these products more available to patients," said Sachs.

Coronavirus

President Joe Biden speaks to members of the media.

Biden administration officials have been deliberating whether to extend the Covid-19 public health emergency declaration. | Evan Vucci/AP Photo

BIDEN ADMIN PLANS TO CONTINUE COVID DECLARATION — The Biden administration is expected to extend the Covid-19 public health emergency declaration again, ensuring that federal measures expanding access to health coverage, vaccines and treatments remain in place beyond the midterm elections, three people with knowledge of the matter told POLITICO's Adam Cancryn and David .

The planned renewal follows extensive deliberations among Biden officials over the emergency declaration's future, including some who questioned whether it was time to let the designation lapse. Under the proposed extension, HHS would continue the declaration potentially into early 2023 — pushing the U.S. into its fourth calendar year under a Covid PHE.

HHS WEIGHING MONKEYPOX EMERGENCY USE AUTHORIZATION PLAN — The FDA may be empowered in the coming days to authorize emergency use of monkeypox vaccines, treatments and tests.

Such a step would mirror the early months of the Covid-19 pandemic when the federal government deployed joint emergency declarations within days to free up funding and staffing and allow FDA emergency use authorizations in addition to no-cost tests and treatments, increased payments to hospitals and expanded telehealth services.

"This declaration would significantly increase FDA's ability to speed the delivery of therapeutics to people suffering from monkeypox," said Stacy Cline Amin, former chief counsel at the FDA during the Trump administration. "There's a sentiment in the industry that this action is urgently needed."

The EUA action, a separate declaration than the public health emergency declared by HHS last week, highlights the differing emergency authorities nested within the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. David and Lauren break down the details.

NOVAVAX SHOT OFFERED ACROSS U.S. AMID GLOOMY FINANCIAL OUTLOOK — Novavax's protein-based Covid vaccine is now being administered in 47 states, the vaccine maker announced Monday ahead of its second-quarter earnings call. The Maryland-based company plans to submit booster dose data to the FDA this month and file for an Omicron-containing dose by the fourth quarter.

But the time it's taking for Novavax to win authorizations for boosters and teens, as well as a drop in demand internationally for the shot, spurred the company to halve its revenue outlook for 2022, The Wall Street Journal reports . It reported a net loss of $510 million in the second quarter, bringing in $186 million in revenue.

Company officials said Monday that they no longer expect to receive an order this year from Covax, a global alliance aiming to vaccinate people in low-income countries. Expanding the vaccine's label to cover other populations and uses is a top priority, they said.

"I believe that, over time, we're going to show that our vaccine will demonstrate longer-lasting protection than other platforms," including as a booster, CEO Stanley Erck said on the call.

Around the Agencies

NIH-BACKED STUDY UNDERPINS FEDS' DOSE-SPARING DEBATE — The Biden administration is using a 2015 study funded by the National Institutes of Health to support a potential dose-sparing recommendation for the monkeypox vaccine to help stretch supply, POLITICO's Erin Banco reports.

The National Institute of Allergy and Infectious Diseases is studying the approach for the FDA-approved Jynneos vaccine, but that could take months to complete. In the meantime, the agency is relying on the older study, which shows the shot could be administered between layers of skin with a smaller-than-usual dose and remain effective.

MEDICAL DEVICES

OIRA FINISHES OTC HEARING AID FINAL RULE REVIEW — The White House Office of Information and Regulatory Affairs completed its review of the FDA's over-the-counter hearing aid final rule, clearing a path for the long-awaited regulation to be published in the Federal Register and subject to public comment.

Industry Intel

PFIZER LAUNCHES LATE-STAGE LYME DISEASE VACCINE TRIAL — Pfizer said Monday it's beginning a Phase III clinical trial of a Lyme disease vaccine candidate in partnership with Valneva. The companies plan to enroll about 6,000 participants ages 5 and up at sites across the U.S. and Europe, with a goal of applying for FDA approval in 2025, pending the study's results.

Quick Hits

Sen. Tim Kaine (D-Va.) spoke with POLITICO's Alice Miranda Ollstein about his own long Covid struggles and his frustration with congressional stalls on legislation that would help others living with it.

Document Drawer

The FDA is inviting comment on the information collection tied to the agency's medical device Q-Submission Program, a mechanism that would enable manufacturers to provide feedback to insurers before a pre-submission meeting.

The FDA announced it is holding a Vaccines and Related Biological Products Advisory Committee meeting on Sept. 22 to discuss Rebiotix's biologics license application for Rebyota, a product intended to reduce the recurrence of clostridioides difficile infection after antibiotic treatment.

 

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